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EXECUTIVE SUMMARY

This project, in the National Research Council's Board on Radiation Effects Research, evaluates the impact of the current policy related to low-level radioactive waste (LLRW) management on biomedical research, particularly in universities and medical centers. The objective of this project is to assess the effects of factors such as higher disposal costs and onsite storage on the current and future activities of biomedical research, including the effects of lack of access to disposal facilities on institutions that conduct biomedical research and on hospitals where radionuclides are crucial for the diagnosis and treatment of disease.

Radioactive waste from biomedical research includes laboratory solutions containing radionuclides, counting vials for assessing radioactivity, biological materials such as tissue-culture cells and animal carcasses, and materials that come into contact with radioactive substances, such as glass or plastic containers, gloves, paper and other absorbent materials for containing spills, and filters. Diagnostic and therapeutic patient-care procedures can also generate radioactive waste. The management of these wastes typically follows a series of steps. First, most of these materials contain short-lived radioactive materials and are stored for decay to essentially nonradioactive materials before being disposed of as nonradioactive waste. Second, remaining radioactive materials are typically managed using methods such as compaction, supercompaction, or incineration. Finally, products of these treatment processes are disposed of as LLRW in local landfills as authorized by specific license conditions.

This report of the Committee on the Impact of Low-Level Radioactive Waste Management Policy on Biomedical Research in the United States, summarizes what is known and not known about the impact of policy regarding LLRW management on biomedical researchers. In addition to assessing the severity of the problem, the report, to the extent possible, identifies techniques that some institutions have used to solve problems and highlights methods that have been and are used successfully to reduce the volumes of LLRW and mixed waste. The report also describes the changes that are occurring in laboratories regarding the use of radioactive and nonradioactive methods and ascertains the impact of these changes on research outcomes and LLRW policy.

The recurring theme of this report is that the major driver of biomedical-LLRW management is cost. When disposal was inexpensive, it was used and pretreatment of waste was not as common. When disposal became expensive, there was a shift to a greater use of alternatives, such as storage for decay (although this practice had been in use for some time), volume reduction including compaction, supercompaction, and incineration, and the use of nonradioactive materials in biomedical applications. These methods of LLRW management are appropriate, safe, and environmentally sensitive. The committee heard no evidence of environmental emergencies resulting from current policies. However, the management of LLRW by biomedical generators is becoming very expensive. Furthermore, the costs to manufacturers of radioactive materials and radiopharmaceuticals will likely increase if these suppliers are required to dispose of



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Page 1 EXECUTIVE SUMMARY This project, in the National Research Council's Board on Radiation Effects Research, evaluates the impact of the current policy related to low-level radioactive waste (LLRW) management on biomedical research, particularly in universities and medical centers. The objective of this project is to assess the effects of factors such as higher disposal costs and onsite storage on the current and future activities of biomedical research, including the effects of lack of access to disposal facilities on institutions that conduct biomedical research and on hospitals where radionuclides are crucial for the diagnosis and treatment of disease. Radioactive waste from biomedical research includes laboratory solutions containing radionuclides, counting vials for assessing radioactivity, biological materials such as tissue-culture cells and animal carcasses, and materials that come into contact with radioactive substances, such as glass or plastic containers, gloves, paper and other absorbent materials for containing spills, and filters. Diagnostic and therapeutic patient-care procedures can also generate radioactive waste. The management of these wastes typically follows a series of steps. First, most of these materials contain short-lived radioactive materials and are stored for decay to essentially nonradioactive materials before being disposed of as nonradioactive waste. Second, remaining radioactive materials are typically managed using methods such as compaction, supercompaction, or incineration. Finally, products of these treatment processes are disposed of as LLRW in local landfills as authorized by specific license conditions. This report of the Committee on the Impact of Low-Level Radioactive Waste Management Policy on Biomedical Research in the United States, summarizes what is known and not known about the impact of policy regarding LLRW management on biomedical researchers. In addition to assessing the severity of the problem, the report, to the extent possible, identifies techniques that some institutions have used to solve problems and highlights methods that have been and are used successfully to reduce the volumes of LLRW and mixed waste. The report also describes the changes that are occurring in laboratories regarding the use of radioactive and nonradioactive methods and ascertains the impact of these changes on research outcomes and LLRW policy. The recurring theme of this report is that the major driver of biomedical-LLRW management is cost. When disposal was inexpensive, it was used and pretreatment of waste was not as common. When disposal became expensive, there was a shift to a greater use of alternatives, such as storage for decay (although this practice had been in use for some time), volume reduction including compaction, supercompaction, and incineration, and the use of nonradioactive materials in biomedical applications. These methods of LLRW management are appropriate, safe, and environmentally sensitive. The committee heard no evidence of environmental emergencies resulting from current policies. However, the management of LLRW by biomedical generators is becoming very expensive. Furthermore, the costs to manufacturers of radioactive materials and radiopharmaceuticals will likely increase if these suppliers are required to dispose of

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Page 2 radioactive materials. The costs for managing LLRW will be passed on to the purchasers of their products. As costs mount, additional research funds are expected to be diverted to LLRW management. The biomedical research effort cannot indefinitely absorb a continuously and sharply increasing cost of this service. Eventually, some other approach must be found to contain these costs. Understanding the economic basis of LLRW management is a key factor in developing policy that can be sustained and used for planning. In general, economic factors drive the choices in LLRW management, and economic factors need to be incorporated into policy development. The committee concluded that the current situation is manageable but expensive. Continuing inflation of LLRW costs at the current rate of increase could interfere with research efforts, and in particular, with the management of LLRW costs as a component of overhead. New technologic developments in nuclear medicine diagnostic and treatment procedures and in molecular biology tracer methodologies could result in a substantial increase in use of radioactive materials. The possibility of an unscheduled and arbitrary closure of one of the remaining disposal facilities is a risk that would force generators to respond quickly with alternative management strategies for LLRW. This will be seriously disruptive, and it will take regulatory or political will and user support to respond and perhaps prevent such an occurrence. It is important to understand that the process of LLRW disposal management policy must make financial sense. Therefore, the committee recommends that institutions engaged in biomedical research carefully assess their LLRW management practices for cost effectiveness. Furthermore, the committee recommends that funding agencies modify their support mechanism for infrastructure costs to pay their fair share of the cost of LLRW management and disposal. Agencies engaged in the support of biomedical research need to take into consideration that the costs of radioactive-waste management, a necessary component of research, have risen sharply in recent years. The regulatory environment for the biomedical research community is complex; any efforts that the regulatory community could make to simplify or streamline the regulatory requirements for managing LLRW without compromising worker or public health and safety would be a benefit. The committee recommended that institutional efforts to promote the use of appropriate alternatives to radioactive materials for research are useful and should be commended and strongly encouraged. The biomedical research community has adapted to the changes that have occurred thus far in LLRW access and cost. However, the committee has no assurance that additional stresses on the system will be as well tolerated over the longer term.